.As a Clinical Trials Laboratory Manager, you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.You will be partnering with a pharmaceutical company committed to discovering and developing treatments that improve and save people´s lives.
Working in this program you will feel challenged and supported to advance in your professional career while making a truly impact.What you will be doing:You will be part of the Human Biological Samples Management (HBSM) team that supports Clinical Trials involving Human Biological Samples (HBS) that are collected, stored, transferred, analyzed, and destroyed as part of the clinical trial.
The management of the HBS and associated laboratory activities needs to be coordinated in a manner that ensures compliance (ethical, legal, and regulatory) and quality to appropriate standards.In this role, you will be responsible for the operational set-up & follow-up of central laboratory (CL) related activities for a project or a group of studies to guarantee alignment amongst the entire network and with Clinical Operations to support delivery of laboratory results.Responsibilities:You will be responsible for a project or a group of studies, ensuring effective interface between Central Laboratory (CL) and a Clinical Study Project Management Team, Precision Medicines & Vaccines Clinical Laboratory & Assay Portfolio, Human Genetics, by providing support related to Human Biological Samples Management (HBSM).Input in study protocol development (mainly clinical laboratory part), Central Laboratory (CL) setup including CL instructions for investigator sites.Be the main point of contact for the clinical study team and Central Laboratory.Responsible for overview of Human Biological Samples Management in the assigned projects including support for investigator sites (mainly based on cooperation with Local Study Managers) and testing issues in Central Laboratory.Oversight of the chain of custody of Human Biological Samples throughout the lifecycle of the study, including site - central lab and provide consultations for HBSM team.Follow up on study KPIs, identify trends, and ensure problems with HBSM are addressed.Act as Subject Matter Expert (SME) for one or several processes of the team.First point of Central Laboratory escalation for the clinical study teams.
Understand, mediate and solve complex issues related to deliverables and escalate as required.Monitor study-related activities to provide management with consolidated information on central laboratory, sample management, data delivery, CL budget review & annual forecast as well as key performance indicators to surface HBSM issues.Support external and internal project audits in CL/HBSM part.Support CL database reconciliation with all CL related issues based on strong cooperation with assigned Data Manager.You are:Master's degree in medical/life sciences or equivalent background